GxP Lifeline

Showing items tagged as Pharma

Three Ways to Accelerate Your Lean Journey

4 October 2017 by Dan Markovitz, Founder, Markovitz Consulting

I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).
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Anticipating Tensions Between Clinical Care and Study Protocol

3 October 2017 Laurie Meehan, Social Media Manager; Polaris Compliance Consultants, Inc.

Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets? There’s a lot to consider.
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ISO, Regulatory Requirement Changes Loom

1 September 2017 B. Christine Park, Consultant, Christine Park & Associates

As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes. Here are a few of the recent changes:
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EU Policy 70 and Redaction — PleaseReview’s Take on It

1 September 2017 by David Cornwell, Founder/CEO, PleaseTech Ltd.

This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.
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Good Communication Skills are Key for Inspection Readiness

25 August 2017 UL

When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you
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Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

24 August 2017 by Stephanie Gaulding, CQA, CPGP, DPS Engineering

I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.
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Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

22 August 2017 by James Jardine, Staff Writer, MasterControl

At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider
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6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

8 August 2017 by Alex Butler, Manager Medical Device Solutions, MasterControl

Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers
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Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

25 July 2017 by Jamie Arnott, Project Director and Caitlin Hirschman, Clinical Team Lead, Rho

When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.
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How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

18 July 2017 Greg Peckford, Founder, Quality Career Advancement

Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.
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Developing a Quality System on a Managed Budget

11 July 2017 by Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.

Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.
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Why the Supply Chain Is so Important Toward Supporting Business Success

6 July 2017 by Bob Ferrari, Managing Director, The Ferrari Consulting and Research Group, Founder and Executive Editor, Supply Chain Matters blog

I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the
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An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

29 June 2017 by Marci Crane, Staff Writer, MasterControl

A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.
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Combination Products and CGMPs: What You Should Know

27 June 2017 Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

At the beginning of this year, the FDA issued final guidance for Current Good Manufacturing Practice (CGMPs) Requirements for Combination Products. This guidance is for therapeutic and diagnostic products that combine drugs, devices, and/or biological products. This guidance has become increasingly necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines
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The Quality Metrics Journey

15 June 2017 by Susan Schniepp, Fellow, Regulatory Compliance Associates Inc

One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.
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Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

8 June 2017 by Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.

While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?
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Why It’s Time to Revisit FDA’s Quality by Design

1 June 2017 Cindy Fazzi, Staff Writer, MasterControl

Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.
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When GCP & GMP Meet

30 May 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.
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The 15 Strangest Phobias and Why They Include the Fear of Paper

23 May 2017 Marci Crane, Staff Writer, MasterControl

It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.
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Keeping Up With the Top Pharma Industry Trends of 2017

18 May 2017 James Jardine, Staff Writer, MasterControl

A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.
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